Digital Documents Control to Achieve the ISO 9001 Standard Requirements

Ever happened to you that your employee used the wrong document and caused a mass? Ever happened to you that a classified information reach the wrong hands and embarrassed you? Ever happened to you that you lost an important document and knew that your boss would get angry? For no reason? If do, please pay attention!

Using Document Control Software usually meets the ISO 9001 Standard Document Control Requirements. The document control requirements is one of the key elements of the ISO 9001 Standard requirements for achieving an effective quality management system. Without reliable control of procedures and records, a company’s QMS integrity will fail – as a practical business matter and as an auditable compliant system.

There are many solutions today for Documents control both manual and digital. In this article I will examine how one can achieve the requirements with digital solutions. Pay attention, we didn’t write software but a digital solution. Digital solution must not be a document control software

There are two kinds of documentations in organizations. The first is the ISO 9001 documentation requirements. For The second, (other than is required) the organization must identify and document “needed” processes (activities with inputs and outputs). Of course documentation should be appropriate for the size and type of the organization, the complexity and interaction of processes, and the competence of personnel. In other words, don’t go over your heads, you would regret it in the future. The purpose is not to turn the organization to be a secretary for the ISO 9001 Standard.

The first level of digital documents control

The first level of digital documents control over organizations is laid with its management systems. Management systems are software designed to support some of the working processes. The system can be an ERP system, a CRM system or any other system. As long that it documents the working processes. Within the system forms are implemented (screens). The system guides you to fill the correct information at the correct location. Eventually, the information is at the right place and time, organized and being controlled. Even distribution of the information is managed. This is what documents control is all about. So, when you are documenting your QMS and prepare yourself for the terrifying audit, any process that is included within the QMS and is documented via the management system – is covered. But you will have to mention it in the procedure. Don’t say I didn’t tell you.

Basic electronic systems

The most common digital way today is still using the local computer network and email systems for documents control. The Documents management is usually being realized when folders or directories are established and usually it is done locally (a department or a division). The documents are saved on the server for use. Sometimes the system administrator or maybe the quality manager requires that the document would be protected by any changes – the “read only” possibility. The types of documents are varying from forms, procedures, records, plans, work instruction, diagrams etc.

As for routing documents, the email as become the main communication channel. People send as attachments documents for review or for use.

Now, you may think that this is a digital documents control but in fact you only get digital documentation but no control what so ever! Why? First, when you save a document on the server it is actually a manual management and not a digital management. It is correct, the document is digital but the management is manually. The employee saves it in the folder and names the document. He has full control over it. God knows what he is capable of doing with it. Digital document management requires that the document would be submitted via the documents control management system. This way, the system is registering the document and then begins managing his lifecycle. Now, no employee of yours registers any document that he saves on the local net. Correct me if I am wrong.

Second, when you send an email with an attachment it is like exporting a document out of his system and into an individual independent lifecycle. The person who receives this attachment would probably save the massage with the document and whenever he would need it, he would brows through his mails the get the document. Everybody does it. He could make changes and you wouldn’t know anything about it. Tracking those documents, comments made by reviewers, and the final approval history are not automatically accessible in a manual email routing system (which are the common ones). Even if documents are sent through email, system administrators must manually track, update, and communicate the review they receive. To make it more clearly, it is an open loop system. Not to mention the ineffective storage results.

With digital document management system you won’t send the document but a link or any other trigger to access the document via the documents control management system.

Third, even when you save a document and you characterize it as “read only” – that prevents no one from saving the document on his computer, edit it and spread it throughout the organization. Again you are back to an open loop system. Sorry. O.K. Even with the strongest most sophisticated digital documents control management systems you can never, really, prevent that. No matter what anyone tells you. You are depending on your employee and his willing to follow ground rules to ensure regulatory compliance. At the end of the day, we are stuck with the human factor.

So with manual (as if – digital) document control we achieve three things: an open loop method for document management, a document exporting out of the loop and an independent lifecycle for documents. The three things the ISO 9001 Standard is trying to avoid.

Solutions Solutions

The first solution that we offer you is to maintain the present situation (the manual, so called “digital”, management). You must have to support it with documented procedure that describes how one must handle documentation (that is the ISO 9001 Standard requirement) and maintain close control aspects. That would hold against the ISO 9001 Standard but I recommend to overview the requirements just to be sure that you obtain the requirements.

The second solution that I can think of is documents control via the management system. What I mean is that all documentation would be concentrated at one location. Documents are a part of a processes. Some of the processes is documented within the management systems (such as ERP or CRM) and some of it manually (with manually forms). In most systems (the ones that I know) the next module exists. It is a less used module. It is usually called “Titles Management”. The basic idea is to link documents to the process or a record connected with the process within the system. This way you educate the employees to download the documents from one location only. No more documents emailing, no more saving documents on personal computers. This solution requires that all documents would be registered within the system (what a whole a lot of work!). For more details, access your system administrator. This solution is not the perfect one but it would hold against the ISO 9001 Standard requirements. Don’t forget to document the method in a procedure.

If you are willing to invest more of your resources you might consider implementing documents control management software.

Documents control management system

Now, this is the optimal solution. Every quality manager would sleep better at night if he knew that all documents are controlled by a robot (without any feelings and wills other then what is programmed into him). Let’s review the advantages of implementing document management software:

Control- this is the most important thing (by the way this is what the ISO 9001 Standard is all about, well, most of it). What do you control?

Organization – all documents of all kinds (forms, procedures, plans, diagram and charts – whatever you are using) would be organized, categorized, saved and ready for you to retrieve and use.

Distribution – to whom the documents are to be used.

Compliance – with your regulatory frameworks.

Access information – now, you may think that you have access to most of information in your organization but you would be surprised. With documents control management software you would have the information you need accurately and you would be able to track all documents-related activities to improve quality, accountability and productivity – that means that all information is accessible when ever.

Location – the system will manage the location of all documents. No more spreading documents all over the local net.

Storage – you would be able to save storage by eliminating multiple documents savings (well, we know that today digital storage is not such a big deal) but Physical storage and retrieval of hard copy documents becomes increasingly problematic as practices grow. And you know it!

More?

This solution costs. It costs money and human resources – have no doubts about that! But we truly believe that in the long term it pays itself by adding values to the working processes. All of the advantages above are possible to achieve manually by your employees but they are time consuming. And time is money.

Today there are two possibilities of digital documents control systems: web-based and independently installed.

The web based solution is simply subscribing to a web site that provides you documents control service. That means that the entire above are provided via the internet. Sounds great isn’t it? As an Internet service, there is no software or hardware to buy, install, maintain, or upgrade. And if the service is not satisfying, just unsubscribe. That’s it. You may access from wherever you are and provide workspaces for people working from home.

The independently installation is where you purchase a software and install it no your network. You may want it to integrate with your other systems. Now, that will be great for a working process! Today they are usually easy to implement and easy to use and with prices that won’t get your boss upset (too much).

Summery

Using Document Control Software usually Meet ISO 9001 Standard Requirements.
As for more documentation (other than what is required by the ISO 9001 Standard) the organization must identify and document “needed” processes.

The first level of digital documents control over organizations is laid with its management systems. Eventually, the information is at the right place and time organized and being controlled. Even distribution of the information is managed.

Saving documents on the local net is not considered a digital documents control management. It is a manual management.

Emailing documents for use is exporting documents out of the system and out of control.

With manual (as if – digital) document control we achieve three things: an open loop method for document management, a document exporting out of the loop and an independent document lifecycle.

First solution is to maintain the present situation (the manual management). You must document the procedure and maintain close control aspects.

Second solution is documents control via the management system with a module such as “Titles management”. This solution requires that all documents would be registered within the system. You must document the procedure.

Third solution is implementing a digital documents control management system. This solution requires a lot of resources (both financial and human) but it bears a lot of advantages.

The first type of a digital documents control management system is an independently installation – you purchase the software and install it on your organizations systems. It may integrate with your other systems.

The second type of a digital documents control management system is a web based program – you buy a service for managing your documents via the net.